Novavax Inc (NVAX)

[JoeForkeyBolo]

Looks like we may have experienced the bottom this week, and with the volume over last 2 days, a lot of the shorts may be covering before BLA approval is announced, followed by CIC trial results and high likelihood of additional partnerships announced over the summer.

[JoeForkeyBolo]

The departure of FDA's Peter Marks is very welcomed news for Novavax shareholders. He was given the choice of resigning or being fired by the Trump administration. RFK Jr. is tasked with cleaning up the FDA and HHS, and Marks was well-known to be a Pfizer puppet.

Marks was instrumental in the numerous delays experienced by Novavax in every aspect of the FDA approval process. He gave preferential treatment to Pfizer and Moderna in the Covid vaccine space, such as delaying EUA approval status of the Novavax vaccine for weeks or months to give the mRNA vaccines a chance to capture market share every year since the Covid outbreak.

I watched the 2024 advisory panel meeting where the 16 members overwhelmingly voted for Novavax's decision to target the JN.1 lineage ("trunk of the tree" reasoning). Marks was visibly agitated and became confrontational since they didn't choose the KP.3 strain that Pfizer was targeting. He earned the title "Milkman" with his reasoning that folks buying milk at the grocery store always choose the freshest milk, not the milk that has closer expiration dates. A week after the committed unaminously voted for JN.1, Marks overrode the committee and the FDA officially targeted the KP.3 Covid strain, stating the Novavax vaccine could be used as an alternative to mRNA if people wanted a choice, but at the risk of lesser protection against the currently circulating KP.3 strain. But as the committee had already discussed, KP.3 was not expected to be the dominant strain by the time the vaccine was ready for use in the fall 2024 to spring 2025 season, and JN.1 would provide more than adequate protection against whatever strain was dominant since it was the "trunk of the tree" for the lineage of the viral strains. Again, Marks used his position to promote his favorited mRNA vaccines and delay Novavax EUA approval by more than a week.

While the impact of Marks' resignation may have negatively impacted all virus makers stock prices, including Novavax, it actually benefits Novavax by removal of a major and recurring roadblock in their dealings with the FDA. Shareholders on other message boards I read are overwhelmingly positive about Marks getting canned, and want the Trump administration to investigate his bias and actions at FDA for violating the integrity of the institution and failure to serve the best interests of the American people vs. serving the best interests of Pfizer. They expect his Pfizer masters to offer him a cushy position in an advisory role, a practice the Trump administration has stated they will want to eliminate as part of returning credibility to the FDA.

Most shareholders are not overly concerned about the existing debt as CEO Jacobs has been successful at eliminating debt and transferring short-term debt to long-term debt to provide additional time for the partnership and licensing strategy to generate sufficient revenue. Novavax is in a pretty strong financial situation currently, and Jacobs has announced two top-10 pharma companies are currently testing Matrix-M in their labs and licensing deals could come at any time. Plus, the Sanofi deal is going well and the upcoming BLA approval will generate another $175M in milestone payment. CIC trial data due over summer, and expanded Sanofi deal is expected as well.

Regardless of current share price, which is largely due to continued shorting, I feel the future of Novavax is very promising and shareholders who don't panic will be greatly rewarded.

[BottomBounce]

$NVAX Total Debt (mrq) $263.47M https://www.cnbc.com/2025/03/31/vaccine-stocks-fall-after-fdas-peter-marks-resigns-over-rfk-jr.html

[IHuser]

imo...

WHaT a PoS~ NVAX



NVAX




IHuser

[JoeForkeyBolo]

The industry heavyweight behind Novavax’s push to bounce back
PharmaVoice
March 25, 2025

Audio version

https://www.pharmavoice.com/news/novavax-ruxandra-draghia-akli-covid-vaccine/743368/?utm_campaign=Yahoo-Licensed-Content&utm_source=yahoo&utm_medium=referral

[JoeForkeyBolo]

These are my predictions for Novavax.

—— 2025 ——————————————————————————————

  •  FDA approves BLA - triggering $175M milestone payment from Sanofi
  •  Sanofi expands 2024 agreement following BLA approval
  •  Positive CIC Phase 3 clinical trial results are announced
  •  New pharma partner announced for CIC vaccine following trial results
  •  A top-10 pharma licenses Matrix-M adjuvant for use with their assets
  •  Another top-10 pharma licenses Matrix-M
  •  New pharma partner for at least one Novavax pipeline asset

—— 2026 ——————————————————————————————

  •  One of the partners/licensees makes acquisition offer for Novavax
  •  Acquisition bidding war ensues among partners and/or other pharmas
  •  Novavax shareholders receive triple-digit share price upon acquisition

[vinmantoo]

I'm making this about Novavax because this is the Novavax investors board.

If you want to discuss how Kennedy's appointment and actions might impact Novavax, that's fine. If you simply want to use this board to voice your opinions and dislike of Kennedy, please find another board.

Kennedy being a serial liar and anti-vaxxer is relevant to NVAX. It isn't about my dislike of him, which is real. It is about him being an unqualified liar whose opinions and actions will damage the US and the health of Americans

[JoeForkeyBolo]

I'm making this about Novavax because this is the Novavax investors board.

If you want to discuss how Kennedy's appointment and actions might impact Novavax, that's fine. If you simply want to use this board to voice your opinions and dislike of Kennedy, please find another board.

[MarauderVoyager38]

I'm also quite curious what Novavax covid vaccine does to bone marrow memory cells. We now know that mRNA shots do not produce these cells, which is a normal function of vaccination. I expect Novavax to come out with a publication confirming their vaccine does induce these cells, similar to other protein based shots.

[vinmantoo]

I had the measles as a kid, and so did everyone else I grew up with, and none of us were harmed from the event. So it's difficult for me to find fault with his comments, as they are correct. However, if there is a proven vaccine against measles, that is an option for people to choose.

I am glad you and people you knew weren't harmed when you contracted the measles. However, your personal experiences are irrelevant. Many people died each year or were hospitalized each year after contracting measles. Kennedy is unqualified to make judgements and he is a liar and a conman.

https://www.cdc.gov/measles/about/history.html

Measles might be a bigger problem than most realize.

https://time.com/7266454/measles-outbreak-essay-ashish-jha/

The problem is, America has lost faith in the FDA and other government health agencies we thought were working to protect us. But we are finding more evidence each day they have been primarily focused on promoting drugs and vaccines to increase profits of big pharma. The scrutiny the FDA has given the Novavax Covid vaccine compared to how little testing, if any, was required for the mRNA vaccines, is a prime example. And now more evidence of significant harm to humans from these mRNA vaccines is surfacing, yet FDA continues to promote them and stand by their prior decisions.

Yeah, conmen like Kennedy and other anti-vaxxers have done a lot of damage. mRNA vaccines aren't dangerous and are effective. NVAX's vaccine is quite good too.

If you're a Novavax shareholder and feel you are correct in your assessment of Kennedy and the impact on Novavax, perhaps it's time to reevaluate your position as a shareholder. I try to encourage people to follow their convictions, especially regarding investments.

Why are you making this about NVAX? It isn't. I hope you make a lot of money on NVAX. Kennedy is a lying conman and is dangerous. That is the point.

[JoeForkeyBolo]

I had the measles as a kid, and so did everyone else I grew up with, and none of us were harmed from the event. So it's difficult for me to find fault with his comments, as they are correct. However, if there is a proven vaccine against measles, that is an option for people to choose.

The problem is, America has lost faith in the FDA and other government health agencies we thought were working to protect us. But we are finding more evidence each day they have been primarily focused on promoting drugs and vaccines to increase profits of big pharma. The scrutiny the FDA has given the Novavax Covid vaccine compared to how little testing, if any, was required for the mRNA vaccines, is a prime example. And now more evidence of significant harm to humans from these mRNA vaccines is surfacing, yet FDA continues to promote them and stand by their prior decisions. Want to explain why it takes so long for Novavax to obtain the BLA? They made the request and data submission last June. I believe FDA intentionally scheduled review for 10 months later once again to give preferential treatment to mRNA vaccines over Novavax, which continues to operate under EUA. Since Kennedy is a fan of Novavax, I expect he will dig deeper into this.

It doesn't help when we see FDA officials who were key decision makers leaving FDA for lucrative careers in the same BP's they supposedly regulated. This is a major conflict of interest, which I hope Trump and Kennedy will end.

If you're a Novavax shareholder and feel you are correct in your assessment of Kennedy and the impact on Novavax, perhaps it's time to reevaluate your position as a shareholder. I try to encourage people to follow their convictions, especially regarding investments.

[vinmantoo]

Speaking of misinformation, your prior post is full of it.

None so blind as those who refuse to see. Kennedy is dangerous and a liar.

https://www.thedailybeast.com/rfk-jr-it-would-be-better-if-everybody-got-measles/

[JoeForkeyBolo]

Speaking of misinformation, your prior post is full of it. Kennedy has spoken numerous times he isn't anti-vax, and has spoken positively about Novavax on more than one occasion. He and his entire family are vaccinated. That's a fact. Also, anyone who has been awake over the last couple of years knows Novavax has been held to a much higher standard by FDA than the mRNA vaccine makers. That's why Novavax is still under EUA for their Covid vaccine while mRNA vaccine makers are fully approved. Novavax has proven higher efficacy and longer lasting with fewer side effects than mRNA, yet still not fully approved.

Kennedy isn't a fan of vaccines PERIOD. NVAX is held to the SAME standard as mRNA vaccines.

[vinmantoo]

Kennedy is a lying conman who spread misinformation about vaccines and touts quack preventatives and cures.

[JoeForkeyBolo]

During the TD Cowen 45th Annual Health Care Conference on 3/4/25, CEO John Jacobs announced another top-10 pharmaceutical company that signed an MTA to experiment with Matrix-M across their pipeline, and this makes 3 top-10 pharmaceutical companies working with Matrix-M across assets in their pipeline and in their labs. This is stated by Jacobs at 1:40 in the audio, which can be accessed at the link below.

This is a clear indication that others besides Sanofi are interested in Matrix-M and we should expect new partnerships, which according to Jacobs in the recent earnings presentation, "could be announced at any time."

The current share price is a gift, in my opinion. I expect the share price to be multiples higher in 2025.

https://wsw.com/webcast/cowen177/nvax/2045967

[JoeForkeyBolo]

If Kennedy isn't a fan of vaccines, then why is he and his entire family vaccinated? Kennedy is a fan of good science regarding testing and approval of vaccines, not FDA officials signing off because that's what their big pharma masters have directed them to do.

Trump and Kennedy need to end the practice of officials leaving FDA for lucrative careers in big pharma. A 5 or 10-year ban following departure from FDA would be appropriate and much needed to help restore trust and accountability to the agency.

[vinmantoo]

Kennedy is not a fan of mRNA vaccines nor the FDA's willingness to approve them with very limited data, while holding others like Novavax to a much higher standard.

Kennedy isn't a fan of vaccines PERIOD. NVAX is held to the SAME standard as mRNA vaccines.

[Big P1]

MAYBE MORE TIME DOING DD ON THIS STOCK INSTEAD OF OTHER STOCKS MIGHT HELP YOU GET INVEST #PIB

[Big P1]

WOW, TOLD YA'LL TO SELL THIS STOCK.

[MarauderVoyager38]

"Shortly after President-elect Donald J. Trump nominated Robert F. Kennedy Jr. to lead the Department of Health and Human Services (HHS), the biotech market — specifically those involving vaccines — responded negatively. It wasn’t really surprising. Without getting into the political weeds, Kennedy has long espoused unconventional views of science and medicine that threaten to disrupt business as usual.

To be sure, Kennedy proponents may argue that such disruption is exactly the point: the idea is that for too long, big pharma and big food companies have, for lack of a better word, “poisoned” the American people in the name of the almighty dollar. Specifically, RFK pinned the prevalence of chronic disease and childhood illness on food and drug industries.

Following Trump’s nomination of Kennedy, several top enterprises such as Pfizer (PFE) saw their shares erode. However, one of the few notable exceptions was Novavax (NVAX). One of the rags-to-riches tales during the onslaught of COVID-19, Novavax was on the verge of collapse prior to the public health crisis. Cynically, though, the SARS-CoV-2 virus brought NVAX stock back into the game.

Of course, the recovery story was relatively short-lived. With other companies delivering their solutions to the clinical finish line first, NVAX stock flirted once again with irrelevancy. Ironically, though, Novavax’s key disadvantage at the time — the deployment of a protein subunit vaccine as opposed to the innovative but controversial messenger RNA — could be its saving grace moving forward.

Essentially, what it comes down to is that Novavax delivers science that Trump’s conservative base trusts. Should another health crisis erupt, Novavax would presumably be in a much better position compared to big pharma giants that are on RFK’s naughty list."

https://www.theglobeandmail.com/investing/markets/stocks/NVAX/pressreleases/30336420/options-alert-why-novavax-nvax-could-be-the-biotech-hero-of-trump-20/

[JoeForkeyBolo]

Kennedy has stated his entire family is vaccinated, and he has specifically mentioned Novavax in a positive light on numerous occasions. Kennedy is not a fan of mRNA vaccines nor the FDA's willingness to approve them with very limited data, while holding others like Novavax to a much higher standard. Not sure where you are getting your info, but hey, one should follow their beliefs regarding their investments, even if it is misinformed, so good luck with that move.

I bought 20K NVAX shares on Friday at $8.00. Looking forward to earnings release this week and update on Novavax pipeline of new products. Also, I'm expecting another partnership announcement at any time. The Sanofi deal was announced in conjunction with earnings release, so it's possible the next deal might be announced in the same manner. And then there's the BLA approval in April, and Phase 2/3 clinical trial data on the CIC vaccine this summer. I believe it's a great time to be invested in Novavax.

I'M SELLING ALL MY SHARES MONDAY AT OPEN. Kennedy will kill vaccines

[vinmantoo]

Kennedy will kill vaccines

and a lot of Americans in the process.

[Big P1]

I'M SELLING ALL MY SHARES MONDAY AT OPEN. Kennedy will kill vaccines

[Big P1]

Wouldn't be invested in any company with Kennedy. Vaccines will be a thing of the past..... YBW

[Big P1]

YALE NEWS just reported more side effects with the Covid Vaccine. OUCH

[JoeForkeyBolo]

COVID-like bat virus discovered by researchers in same Chinese lab accused of leaking deadly 2020 outbreak: study

Now the New York Post has the story.
https://nypost.com/2025/02/21/world-news/covid-like-bat-virus-discovered-by-researchers-in-wuhan-lab-study/

This might create a big demand for NVAX stock on Monday, especially if it gets picked up by other news services.

[JoeForkeyBolo]

Another pandemic scare as scientists discover new coronavirus in China

A story in the U.K.'s Daily Mail spurred a sharp rise in Novavax and other vaccine maker share prices mid-day today. I sold out of my NVAX position during the spike and bought back near the end of the day. It was a good opportunity to trade and pick up some free NVAX shares.

The validity of the story suspect, as Daily Mail is regarded as a tabloid. According to Wikipedia:

"The Daily Mail has been criticized for its unreliability, its printing of sensationalist and inaccurate scare stories about science and medical research, and for instances of plagiarism and copyright infringement."

https://www.dailymail.co.uk/galleries/article-14422269/New-coronavirus-pandemic-potential-discovered-China.html

[JoeForkeyBolo]

Novavax to Host Conference Call to Discuss Fourth Quarter and Full Year 2024 Financial Results and Operational Highlights on February 27, 2025

https://ir.novavax.com/press-releases/2025-02-20-Novavax-to-Host-Conference-Call-to-Discuss-Fourth-Quarter-and-Full-Year-2024-Financial-Results-and-Operational-Highlights-on-February-27,-2025

[Big P1]

READ THE BOOK DR. MARY'S MONKEY and see how safe vaccines are. Original Polio vaccine had cancer in it and the government knew it.

[MarauderVoyager38]

https://www.yahoo.com/news/bill-ban-mrna-vaccines-passes-140200324.html

-House Bill 371, sponsored by Rep. Greg Kmetz and co-sponsored by Reps. Tracy Sharp and Lukas Schubert, aims to ban mRNA vaccines, including those for Covid-19, due to safety concerns.
-The bill passed out of the House Judiciary Committee in a 12-8 vote and is now headed to the House floor for further consideration.
-Supporters of the bill argue that mRNA vaccines are harmful, while opponents believe they are safe and removing them limits individual choice in healthcare.

[chrismiss_everyday]

🦠 Hope the H5N1 vaccines are ready ASAP! 🦠

[JoeForkeyBolo]

Two Years Into Novavax Reset, CEO Jacobs Hunts for Silver Linings

BioSpace
January 28, 2025

https://www.biospace.com/business/two-years-into-novavax-reset-ceo-jacobs-hunts-for-silver-linings

[JoeForkeyBolo]

BIOTECH TV Interview with CEO John Jacobs

SF Healthcare Week: After striking a transformational deal with Sanofi, Novavax is ramping up its vaccine pipeline

[JoeForkeyBolo]

January 2025 Corporate Presentation

https://novavax.widen.net/s/wggdm8jtjb/novavax-jan-2025-corporate-deck

[JoeForkeyBolo]

NEWS: Novavax is Powering the Future of Vaccines Through R&D and Value-creating Business Strategy

https://ir.novavax.com/press-releases/Novavax-is-Powering-the-Future-of-Vaccines-Through-R-D-and-Value-creating-Business-Strategy

[TechandBio]

30K profits pre market trading in and out!

Flu/Covid combo Wow all the senior citizens will like this vaccine LOL


$NVAX

[chrismiss_everyday]

Yep…some bitd flu excitement being generated.

[JoeForkeyBolo]

Item 2.01 Completion of Acquisition or Disposition of Assets.

On December 30, 2024, Novavax CZ a.s. (the “Seller”), an indirect, a wholly owned subsidiary of Novavax Inc. (the “Company”), completed the previously-announced sale of the Company’s biologics manufacturing campus located at Bohumil, Jevany, Czech Republic (the “Facility”) to Novo Nordisk Production Czech s.r.o. (the “Purchaser”), pursuant to an asset purchase agreement, dated as of December 3, 2024 (the “Asset Purchase Agreement”), by and among the Seller, the Company, the Purchaser and Novo Nordisk A/S. Pursuant to the Asset Purchase Agreement, the Seller sold, transferred and assigned to the Purchaser: (i) properties owned by the Seller registered on folio No. 894 maintained by the Cadastral Office for Central Bohemian Region, Detached Cadastral Office Prague-East, for the cadastral area Jevany, comprising land in the settlement known as Bohumil, as well as certain moveable assets and equipment located at the manufacturing facility (the “Transferred Assets”); (ii) contracts related to the operation and management of the Transferred Assets (the “Transferred Contracts”); and (iii) certain employees currently providing services related to the Transferred Assets (the “Transferred Employees”). The total purchase price for the Facility was $200 million and the assumption by the Purchaser of liabilities (on a look-forward basis) pertaining to the Transferred Assets, Transferred Contracts and Transferred Employees. On the closing date, the Purchaser received a cash payment of $180 million, net of the initial payment of $10 million made in September 2024 and $10 million placed in an escrow account to be released to the Seller on the date which is 12 months following the closing date (subject to adjustment for any claims the Purchaser may have against the Seller under the Asset Purchase Agreement). Pursuant to the terms of the Asset Purchase Agreement, the Company was also reimbursed approximately $2. 6 million, subject to adjustments, for costs in continuing to operate and maintain the Transferred Assets, Transferred Contracts and Transferred Employees between December 3,2024 and the completion of the sale.

The foregoing description of the Asset Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the Asset Purchase Agreement, which will be filed with the Securities and Exchange Commission as an exhibit to the Company’s Annual Report on Form 10-K for the year ending December 31, 2024.

https://app.quotemedia.com/data/downloadFiling?webmasterId=101533&ref=318815916&type=HTML&symbol=NVAX&cdn=742ca96f5c4d25df192d823f151d9c8a&companyName=Novavax+Inc.&formType=8-K&dateFiled=2024-12-30

[Monksdream]

NVAX, under $9

[JoeForkeyBolo]

NEWS: Novavax Advances Corporate Growth Strategy Through Sanofi Partnership, Including Achievement of First $50 Million Milestone

• Novavax continues to progress Sanofi agreement by achieving first milestone, with additional milestones and ongoing tiered royalties to come, solidifying a strong model for future partnerships

• Novavax's COVID-19 vaccine included in Sanofi's two combination vaccine candidates for prevention of influenza and COVID-19, for which Phase 1/2 trials were initiated and Fast Track designation recently granted in the U.S.

GAITHERSBURG, Md., Dec. 13, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced progress in Q4 2024 advancing its corporate growth strategy through its partnership with Sanofi. The Company has achieved a milestone associated with its Phase 2/3 clinical trial for its COVID-19 vaccine in children, triggering the first $50 million milestone payment from Sanofi.

"Novavax is steadily advancing our new corporate growth strategy. By achieving this milestone in our collaboration agreement with Sanofi, as well as the upcoming sale of our Czech Republic manufacturing site, we are strengthening our balance sheet as well as delivering significant cost reductions," said John C. Jacobs, President and Chief Executive Officer, Novavax. "In addition, Sanofi recently announced it received U.S. FDA Fast Track designation for two vaccine candidates combining our proven COVID-19 vaccine with its market-leading influenza vaccines. These assets have progressed to Phase 1/2 clinical trials, with the potential for future Novavax milestone payments and royalties, if successful."

The $50 million milestone is the first following the initial upfront payment at signing of the agreement with Sanofi in May 2024. Following this payment, there are additional potential milestones of up to $300 million related to Novavax's partnered COVID-19 vaccine that will be recognized in the periods when earned. In addition to milestones for the stand-alone COVID-19 vaccine, the agreement also includes combination products developed by Sanofi including Novavax's COVID-19 vaccine, which present a potential opportunity of up to an additional $350 million for Novavax in future milestones. In addition, both stand-alone COVID-19 sales and potential sales of any Sanofi combination products would net Novavax ongoing tiered royalties. Further, Novavax is eligible to receive up to $200 million for the first four products created by Sanofi utilizing its Matrix-M adjuvant, and up to $210 million in milestone payments for each product including Matrix-M thereafter, plus ongoing royalties for all Sanofi products utilizing Matrix-M.

Novavax's corporate growth strategy includes efforts to pursue additional partnerships for its late-stage and early-stage Research and Development assets and Matrix-M adjuvant alone. This growth strategy should position the Company for ongoing value creation as additional partnerships are secured under a similar contractual framework.

https://ir.novavax.com/press-releases/2024-12-13-Novavax-Advances-Corporate-Growth-Strategy-Through-Sanofi-Partnership,-Including-Achievement-of-First-50-Million-Milestone

[JoeForkeyBolo]

FDA Grants Fast Track Tag to SNY's Two COVID & Flu Vaccine Candidates

Zacks Equity Research
Wed, December 11, 2024

Sanofi SNY announced that the FDA has granted a Fast Track designation to two combination vaccine candidates to prevent influenza and COVID-19 infections in people aged 50 years and above.

NCT06695117, the first vaccine candidate, combines SNY’s influenza protein-based trivalent vaccine, Fluzone High-Dose and Novavax’s NVAX adjuvanted recombinant Novavax COVID-19 vaccine, NVXC19.

NCT06695130, the second vaccine candidate, combines SNY’s influenza recombinant protein-based trivalent vaccine, Flublok with NVXC19.

SNY markets Fluzone High-Dose and Flublok flu vaccines.

Novavax recently signed a multi-billion dollar deal with Sanofi for its protein-based COVID-19 vaccine.

Per the deal, from 2025 onwards, Sanofi will gain rights to co-market Novavax’s COVID-19 vaccine globally, except in certain countries where the company has existing partnership agreements. The French drugmaker also has the sole license to develop and market the Novavax vaccine in combination with its influenza vaccine.

Year to date, shares of Sanofi have lost 3.3% against the industry’s growth of 8.9%.

More on SNY's Combination Vaccine Candidates

Per the company, NCT06695117 and NCT06695130 are the first non-mRNA combination vaccine candidates that include two licensed vaccines for the prevention of influenza and COVID-19 infections.

When administered as a booster dose, Novavax’s NVXC19 has also demonstrated a better tolerability profile than the currently available mRNA COVID-19 vaccines.

NVXC19 has also demonstrated high efficacy against COVID-19 as a primary vaccination in two phase III studies.

Two ongoing phase I/II studies are currently evaluating the safety profile and immune response induced by NCT06695117 and NCT06695130.

SNY Boasts a Strong Vaccine Segment

Sanofi possesses one of the world’s leading vaccine operations, with total annual sales of more than €5 billion in the past five years. The company’s Vaccine unit has delivered mid-to-high-single-digit sales growth since 2018. SNY also has a strong position in both seasonal and pre-pandemic influenza vaccine spaces.

In the first nine months of 2024, the Vaccines unit generated sales worth €6.12 billion increasing 14.5% year over year at a constant currency rate.

Sanofi has at least five vaccine candidates, which are expected to enter phase III development by 2025. SNY expects annual net sales to be more than €10 billion from its Vaccines unit by 2030 backed by the company’s innovation efforts. Sanofi continues to expand its vaccine business further.

Other Players Developing COVID-Flu Combination Shots

Apart from Sanofi, Moderna MRNA and Pfizer PFE are also developing their respective COVID/flu combination vaccines using mRNA technology.

Moderna is developing mRNA-1083, its investigational mRNA-based combination vaccine against influenza and COVID-19. In June, MRNA announced that the phase III study evaluating its COVID/flu combination vaccine, mRNA-1083, in older adults (50 years and older) met the primary endpoints.

Subject to discussions with the FDA, Moderna plans to submit a regulatory filing, seeking approval for the COVID/flu combination vaccine shortly.

Meanwhile, Pfizer suffered a major setback in August when it reported data from a phase III study on its investigational mRNA-based COVID/flu combination vaccine. The study missed one of its two primary immunogenicity objectives.

PFE is currently evaluating adjustments to its combination vaccine program and plans to discuss the next steps with health authorities. Pfizer is developing this vaccine in collaboration with BioNTech.

https://finance.yahoo.com/news/fda-grants-fast-track-tag-152500888.html

[JoeForkeyBolo]

NEWS: Novavax Initiates Phase 3 Trial for COVID-19-Influenza Combination and Stand-Alone Influenza

December 10, 2024

•  Company continuing to work with the U.S. FDA on potential for accelerated approval pathway
•  Novavax intends to partner on both candidates to advance to filing and commercialization

GAITHERSBURG, Md., Dec. 10, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the first participants have been dosed in its COVID-19-Influenza Combination (CIC) and stand-alone seasonal influenza Phase 3 trial. The trial will evaluate the immunogenicity and safety of the CIC and stand-alone seasonal influenza vaccine candidates compared to Novavax's updated 2024-2025 COVID-19 vaccine (NVX-CoV2705) and a licensed seasonal influenza vaccine comparator in adults aged 65 and older.

"A combination vaccine for two vaccine-preventable diseases is an important step forward for public health and the trial start is a key step in advancing our late-stage pipeline, which we plan to progress through strategic partnerships," said Ruxandra Draghia-Akli, MD, PhD, Executive Vice President, Head of Research and Development, Novavax. "Our goal is to get these assets to market as soon as possible, and we will work with the U.S. FDA to assess the possibility of an accelerated approval pathway."

The Company is working with the U.S. Food and Drug Administration (FDA) to determine the potential of the current CIC and stand-alone influenza trial to support accelerated approval. While in the process of seeking alignment on accelerated approval criteria with the U.S. FDA, Novavax has decided to recruit an initial cohort of approximately 2,000 participants while continuing this dialogue. Novavax anticipates being able to provide more clarity and information on potential next steps by Q2 2025, including if additional clinical work would be needed to achieve registration for these assets.

The randomized Phase 3 trial builds on positive Phase 2 data and aims to further evaluate the immunogenicity and safety of a combination of Novavax's updated 2024-2025 COVID-19 vaccine, trivalent nanoparticle stand-alone seasonal influenza vaccine candidate and patented saponin-based Matrix-M adjuvant relative to separate administrations of Novavax's updated 2024-2025 COVID-19 vaccine and a licensed seasonal influenza vaccine comparator. In addition, the trial also aims to further evaluate the immunogenicity and safety of Novavax's stand-alone influenza vaccine, also containing Matrix-M.

The Company's FY 2025 financial guidance for combined Research & Development and Selling, General and Administrative expense of approximately $500 million is inclusive of this CIC and stand-alone influenza initial planned Phase 3 clinical activity and is subject to revisions and updates as next steps are determined.

https://ir.novavax.com/press-releases/2024-12-10-Novavax-Initiates-Phase-3-Trial-for-COVID-19-Influenza-Combination-and-Stand-Alone-Influenza

[JoeForkeyBolo]

NEWS: Novavax Announces Sale of Czech Republic Manufacturing Site to Novo Nordisk for $200 Million

• Agreement provides significant, non-dilutive capital to Novavax, further enabling the Company to advance its corporate growth strategy of driving value from its pipeline assets and proven technology platform

• Provides Novavax with $190 million cash payment in 2024 and additional $10 million in 2025, and annual operating cost reductions of approximately $80 million

GAITHERSBURG, Md., Dec. 4, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that it has signed a definitive agreement to sell its manufacturing facility in Bohumil, Czech Republic to Novo Nordisk for $200 million. The agreement includes a transfer of assets, including a 150,000-square foot state-of-the-art recombinant protein manufacturing facility with support buildings, along with the existing workforce and all related and required infrastructure.

The agreement provides Novavax with significant, non-dilutive capital, further enabling the Company to advance its corporate growth strategy to drive value from its early- and late-stage pipeline using its proven technology platform, consisting of Matrix-M adjuvant and nanoparticle protein-based technology. In addition to the $190 million cash payment in 2024 and additional $10 million in 2025, Novavax expects the sale of the facility to result in annual operating cost reductions of approximately $80 million.

"The decision to sell the Czech Republic manufacturing facility aligns with our previously announced commitment to evolve Novavax into a more lean and agile organization focused on partnering our pipeline assets and technology platform," said John C. Jacobs, President and Chief Executive Officer, Novavax. "We are thankful to our dedicated colleagues in the Czech Republic who have contributed to Novavax's mission of delivering our technology to address unmet needs. We look forward to working with Novo Nordisk to ensure a successful transition."

Following closure of the agreement, expected by December 30, 2024, full responsibility for the manufacturing facility will be transferred to Novo Nordisk.

https://ir.novavax.com/press-releases/2024-12-04-Novavax-Announces-Sale-of-Czech-Republic-Manufacturing-Site-to-Novo-Nordisk-for-200-Million

[JoeForkeyBolo]

Novavax Announces Grant of Inducement Awards Pursuant to Nasdaq Listing Rule 5635(c)(4)

GAITHERSBURG, Md., Nov. 15, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, today announced that the Company granted a non- qualified stock option and restricted stock units to Ruxandra Draghia-Akli, MD, PhD, its newly appointed Executive Vice President and Head of Research & Development, as a material inducement for her entry into employment with Novavax, effective as of November 11, 2024 (the "grant date"). These awards were approved by the Compensation Committee of Novavax and were granted in accordance with Nasdaq Listing Rule 5635(c)(4) and pursuant to the Novavax, Inc. 2023 Inducement Plan.

The non-qualified stock option is an option to purchase 64,150 shares of Novavax's common stock with a per share exercise price of $9.01, the closing price of Novavax's common stock on the Nasdaq Global Select Market on the grant date. The non- qualified stock option has a ten-year term and will vest as to one-quarter of the underlying shares on the first anniversary of the grant date, and as to the remaining shares in equal monthly installments for 36 months thereafter, in each case generally subject to Dr. Draghia-Akli's continued employment with Novavax through the applicable vesting date. The restricted stock units are with respect to 42,770 shares of Novavax's common stock and will vest as to one-third of the restricted stock units on each of the first three anniversaries of the grant date, in each case generally subject to Dr. Draghia-Akli 's continued employment with Novavax through the applicable vesting date. The non-qualified stock option and restricted stock units are subject to the terms and conditions of the Novavax, Inc. 2023 Inducement Plan.

https://ir.novavax.com/press-releases/2024-11-15-Novavax-Announces-Grant-of-Inducement-Awards-Pursuant-to-Nasdaq-Listing-Rule-5635-c-4

[JoeForkeyBolo]

Novavax Reports Third Quarter 2024 Financial Results and Operational Highlights

https://ir.novavax.com/press-releases/2024-11-12-Novavax-Reports-Third-Quarter-2024-Financial-Results-and-Operational-Highlights

[JoeForkeyBolo]

U.S. FDA Removes Clinical Hold on Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Phase 3 Trial

GAITHERSBURG, Md., Nov. 11, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The FDA has cleared the Company to begin enrolling the planned Phase 3 trial following the determination that Novavax satisfactorily addressed all clinical hold issues. Novavax will be working with the clinical trial investigators and other partners to resume trial activities as quickly as possible.

"We thank the FDA for their partnership and thorough review of the additional information provided as part of our response package," said Robert Walker, MD, Chief Medical Officer, Novavax. "The information provided to the FDA supported our assessment that the serious adverse event was not related to our vaccine. We plan to start our Phase 3 trial as soon as possible."

The clinical hold announced on October 16, 2024, resulted from a spontaneous report of a serious adverse event in a participant who received investigational CIC vaccine in a Phase 2 trial that completed in 2023. The FDA had requested additional information on this event, initially reported as motor neuropathy. The additional information included a change in the event term to amytrophic lateral sclerosis, a condition that is not known to be immune-mediated or associated with vaccination, which in this event was assessed as not related to vaccination.

https://ir.novavax.com/press-releases/2024-11-11-U-S-FDA-Removes-Clinical-Hold-on-Novavaxs-COVID-19-Influenza-Combination-and-Stand-alone-Influenza-Phase-3-Trial

[JoeForkeyBolo]

I read on another board that both Pfizer and Moderna reported better than expected Q3 Covid vaccine sales, so with the increased awareness of Novavax vaccine option compared to previous years, hopefully we get better than expected results as well on next Tuesday's earnings call.

Thanks for your recon. Much appreciated.

[ShadowHaven59]

Great news! I just left the CVS and spoke to the pharmacist, the box of vaccines for Novavax for the month of October was all used up. They just received another box for the month of November, so I’m assuming each store. is going to get one box a month. Thank you for all the good information you guys post hopefully the next two CVS stores I pick up at will tell me the same thing. your friendly neighborhood mailman

[JoeForkeyBolo]

Form 8-K Filing

Item 1.01 Entry into a Material Definitive Agreement.

On November 1, 2024, Novavax, Inc. (the “Company”) and The Secretary of State for Health and Social Care, acting as part of the Crown, through the UK Health Security Agency (the “Authority”), entered into a Termination and Settlement Agreement (the “Settlement Agreement”) and a Letter of Amendment to the Settlement Agreement (the “Settlement Agreement Amendment”), relating to the Amended and Restated SARS-COV-2 Vaccine Supply Agreement effective July 1, 2022 (the “Amended and Restated Supply Agreement”) by and between the Company and the UK Secretary of State for Business, Energy and Industrial Strategy, acting on behalf of the Crown, settling the disputes regarding the Amended and Restated Supply Agreement and releasing both parties of all claims arising out of or connected with the Amended and Restated Supply Agreement.

Under the terms of the Settlement Agreement, the Authority and the Company agreed to terminate the Amended and Restated Supply Agreement and to fully settle the outstanding amount under dispute related to upfront payments previously received by the Company from the Authority under the Amended and Restated Supply Agreement. Pursuant to the Settlement Agreement, the Company agreed to pay a refund of $123.8 million (the “Settlement Payment”) to the Authority in equal quarterly installments of 10.3 million over a three year period, ending on June 30, 2027. The Settlement Payment amount includes a $11.3 million provision for interest over the period and may be avoided if the Company chooses to accelerate payments. Under the terms of the Settlement Agreement Amendment, the Authority and the Company agreed to make the first quarterly installment payment due on November 30, 2024.

The foregoing descriptions of the material terms of the Settlement Agreement and the Settlement Agreement Amendment does not purport to be complete and is qualified in its entirety by reference to the Settlement Agreement, which will be filed with the Securities and Exchange Commission as an exhibit to the Company’s Annual Report on Form 10-K for the year ended J December 31, 2024.

Item 1.02 Termination of a Material Definitive Agreement.

In connection with the parties’ entry into the Settlement Agreement, the Company and the Authority terminated the Amended and Restated Supply Agreement.

The information set forth in Item 1.01 of this Current Report on Form 8-K is incorporated herein by reference in this Item 1.02.

Form 8-K

[JoeForkeyBolo]

Novavax to Host Conference Call to Discuss Third Quarter 2024 Financial Results and Operational Highlights on November 12, 2024

GAITHERSBURG, Md., Nov. 4, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced it will report its third quarter 2024 financial results and operational highlights at 8:30 a.m. Eastern Time (ET) on Tuesday, November 12, 2024.

Details of the event and replay are available at the link below:

https://ir.novavax.com/press-releases/2024-11-04-Novavax-to-Host-Conference-Call-to-Discuss-Third-Quarter-2024-Financial-Results-and-Operational-Highlights-on-November-12,-2024